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NCT02840474 · ClinicalTrials.gov registry record · Phase 1
Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT02840474 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 16 participants.
The verdict
NCT02840474, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was completed in 2017. In Part B, the researchers studied VRC07-523LS. Depending on which antibody received, researchers studied the amount of VRC01LS or VRC07-523LS in the body and how it changes over time. They evaluated the effect of antibodies on CD4+ (Cluster of Differentiation 4) lymphocyte count and HIV viral load, and checked to see if people who get VRC01LS or VRC07-523LS develop an immune response to it. Objective: To see if VRC01LS and VRC07-523LS are safe and well tolerated. Eligibility: Adults ages 18-70 who are HIV infected but otherwise healthy. Design: Participants received the study drug one time by IV infusion. A needle guided a thin tube into a vein. The study drug mixed with salt water was dripped into the vein over about 30 minutes. Participants were monitored for 30 minutes after the infusion. Blood samples were taken at the following times: * Once before the infusion * 5 times in the 4 hours after the infusion * 1 time 24 hours after infusion. Some participants may have had 3 optional blood draws in the time period between 4 and 24 hours. For 3 days after the infusion, participants recorded their temperature and reactogenicity symptoms in a diary. There were a total of 23 study visits over 48 weeks. Ten visits were in the first 4 weeks. At all visits, participants answered health questions and gave blood samples.
Interventions
- BIOLOGICAL VRC-HIVMAB080-00-AB
- BIOLOGICAL VRC-HIVMAB075-00-AB
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2020-01-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02840474
The ClinicalTrials.gov registry entry for NCT02840474 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which VRC-HIVMAB080-00-AB is the first listed.
NCT02840474 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02840474 about?
NCT02840474 is a clinical study titled "Phase 1, Open-label, Single Dose Study to Examine Safety, Tolerability, Pharmacokinetics and Virologic Impact of VRC01LS or VRC07-523LS in HIV-infected Viremic Adults". Background: The human body uses antibodies as one way to help fight infection. VRC01LS and VRC07-523LS are antibodies directed against the HIV virus. Researchers want to see if they are safe and well tolerated. In Part A of the study, the researchers studied VRC01LS. Part A of the study was complet...
What is the current status of trial NCT02840474?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2017-04-24. Estimated completion is 2020-01-15.
What interventions are being tested in trial NCT02840474?
The interventions under investigation include: VRC-HIVMAB080-00-AB (BIOLOGICAL), VRC-HIVMAB075-00-AB (BIOLOGICAL).
Who is sponsoring clinical trial NCT02840474?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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